Megace

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For Patients

Megace (megestrol acetate, USP) Oral Suspension is a man-made chemical similar to the female hormone progesterone used to treat loss of appetite and weight loss because of disease, and is also used in the treatment of advanced breast cancer and endometrial cancer. Megace is available in generic form. Common side effects of Megace include weight gain, changes in appetite, stomach upset, diarrhea, gas, skin rash, trouble sleeping (insomnia), decreased sexual ability/desire, impotence, trouble having an orgasm, or fever. Women may experience changes in menstrual periods, including unpredictable vaginal bleeding.

The recommended adult initial dosage of Megace Oral Suspension is 800 mg/day (20 mL/day). Megace may interact with insulin or oral diabetes medicine and may decrease the effects of these medications, and blood sugar levels may increase. If you have diabetes, monitor blood sugar and talk to your doctor if you notice unusual changes. Tell your doctor all medications you use. Megace must not be used during pregnancy. It may cause harm to a fetus. Women of childbearing age should use birth control while using this medication. This medication may pass into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.

Our Megace (megestrol acetate, USP) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS

Clinical Adverse Events

Adverse events which occurred in at least 5% of patients in
any arm of the two clinical efficacy trials and the open trial are listed below
by treatment group. All patients listed had at least one post baseline visit
during the 12 study weeks. These adverse events should be considered by the
physician when prescribing MEGACE Oral Suspension.

ADVERSE EVENTS % of Patients Reporting

Megestrol Acetate, mg/day No. of Patients

Trial 1
(N=236)

Trial 2
(N=87)

Open Label Trial

Placebo 0
N=34

100
N=68

400
N=69

800 N=65

Placebo 0
N=38

800
N=49

1200
N=176

Diarrhea

15

13

8

15

8

6

10

Impotence

3

4

6

14

0

4

7

Rash

9

9

4

12

3

2

6

Flatulence

9

0

1

9

3

10

6

Hypertension

0

0

0

8

0

0

4

Asthenia

3

2

3

6

8

4

5

Insomnia

0

3

4

6

0

0

1

Nausea

9

4

0

5

3

4

5

Anemia

6

3

3

5

0

0

0

Fever

3

6

4

5

3

2

1

Libido Decreased

3

4

0

5

0

2

1

Dyspepsia

0

0

3

3

5

4

2

Hyperglycemia

3

0

6

3

0

0

3

Headache

6

10

1

3

3

0

3

Pain

6

0

0

2

5

6

4

Vomiting

9

3

0

2

3

6

4

Pneumonia

6

2

0

2

3

0

1

Urinary Frequency

0

0

1

2

5

2

1

Adverse events which occurred in
1% to 3% of all patients enrolled in the two clinical efficacy trials with at
least one follow-up visit during the first 12 weeks of the study are listed
below by body system. Adverse events occurring less than 1% are not included.
There were no significant differences between incidence of these events in
patients treated with megestrol acetate and patients treated with placebo.